The long-awaited report by the United Nations High Level Panel on Access to Medicines was released today, making many recommendations. The panel calls for countries to embrace the policy space available in the World Trade Organization intellectual property rules, and invest more in health. It also calls for negotiation of a binding international treaty on research and development, delinking prices from R&D costs, greater transparency in drug pricing, public health impact assessments in free trade agreements, and encouragement to better use international legal tools available to countries to ensure affordable medical products. And it lays out the path ahead, calling for several new bodies to be created to take recommendations forward.

“Never in the past has our knowledge of science been so profound and the possibilities to treat all manner of diseases so great … and yet, many people and communities in need of effective prevention methods, life-enhancing and life-saving treatments and rehabilitation do not receive them,” the report says in opening.

The United Nations High Level Panel on Access was constituted in November 2015 with the mandate to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.

A key aspect of the findings is “coherence,” panellists said in a teleconference today. “An important factor behind the incoherence between human rights, trade, intellectual property and public health lies in the diverse accountability mechanisms and transparency levels of these different, but overlapping spheres,” the report states.

While trade and intellectual property-related accountability mechanisms are regulated by the World Trade Organization Dispute Settlement Body, “human rights and public health accountability mechanisms are characterised by varying and often limited degrees of precision, legal weight and enforceability,” it says.

The report uniquely calls for public health assessments to be done with every free trade negotiation to assess the possible impact on public health, and for the creation of public health patentability criteria.

Michael Kirby, retired Justice of the High Court of Australia and one of the panel members, said today during a briefing organised for journalists that some countries “which have been devout to take advantage of the TRIPS flexibilities guaranteed to them by TRIPS and Doha have suffered consequences from countries ascertaining their intellectual property.”

“One of the key recommendations of the report is that this should not happen, and countries that threaten and retaliate against others for using their entitlements under the TRIPS Agreement will be forced to face significant serious sanctions for doing so,” he said. That requires collaboration by the WTO, which is not a UN agency, he said, but which needs to be brought to the realisation that its members have to comply with the Doha Declaration.

Public Health, TRIPS, Patents

The High Level Panel recommendations calls for WTO members to commit to respect the WTO Doha Declaration on TRIPS [WTO Agreement on Trade-Related Aspects of Intellectual Property Rights] and refrain from any action what would limit its implementation.

Countries should make full use of the flexibilities enshrined in the TRIPS Agreement, and use the policy space available in Article 27 of TRIPS “by adopting and applying rigorous definitions of invention and patentability that are in the best interests of the public health of the country,” including amending laws to curtail the ever-greening of patents and awarding patents only when genuine invention has occurred. Governments are also called to adopt and implement legislation facilitation the issuance of compulsory licences.

“Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities,” the report says. “Instances of undue political and commercial pressure should be reported to by the WTO Secretariat during the Trade Policy Review of Members.”

“WTO Members must register complaints against undue political and economic pressure which includes taking punitive measures against offending WTO Members,” it adds.

The panel also recommends that governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the right to health. Public health impact assessments should be undertaken, inform negotiations, and made publicly available.

The High-Level Panel also recommends that several United Nations agencies collaborate with one another and with other relevant bodies with the relevant expertise to support governments to apply public-health-sensitive patentability criteria. Those UN agencies include the UN Conference on Trade and Development (UNCTAD), UN Development Programme (UNDP), World Health Organization (WHO), World Intellectual Property Organization (WIPO) and the (non-UN) World Trade Organization (WTO).

Publicly-Funded Research: Public Health Priority

According to the report, “universities and research institutions that receive public funding must prioritize public health objectives over financial returns in their patenting and licensing practices.” Those practices include the use of non-exclusive licences, the donation of IP rights, participation in public sector patent pools and other mechanisms that maximize innovation while promoting access, the report says.

The experts also called for governments to increase their current levels of investment in health technology innovation to address unmet needs.

“Stakeholders, including governments, the biomedical industry, institutional funders of healthcare and civil society, should test and implement new and additional models for financing and rewarding public health research and development (R&D), such as the transaction taxes and other innovative financing mechanisms,” it says.

They encouraged negotiations at the WHO for a binding research and development Convention “that delinks the costs of research and development from end prices to promote access to good health for all.” That convention “should focus on public health needs, including but not limited to, innovation for neglected tropical diseases and antimicrobial resistance and must complement existing mechanisms,” they said.

“Governments should strengthen national level policy and institutional coherence between trade and intellectual property, the right to health and public health objectives by establishing national inter-ministerial bodies to coordinate laws, policies and practices that may impact on health technology innovation and access,” the report indicates.

Independent Review Body to Assess Progress

They called for the United Nations Secretary-General to establish an independent review body tasked with assessing progress on health technology innovation and access, which would monitor challenges and progress on innovation and access to health technologies under the ambit of the UN 2030 Agenda, and progress made in implementing the recommendations of the High-Level Panel on Access to Medicines.

Membership of this review body should include governments, representatives from the UN and multilateral organisations, civil society, academia, and the private sector.

Separately, the report calls for the UN Secretary-General to establish an inter-agency taskforce on health technology innovation and access. “This taskforce, operating for the duration of the SDGs, should work toward increasing coherence among United Nations entities and relevant multilateral organizations like the WTO.”

The report envisages a Special Session of the UN General Assembly no later than 2018 on health technology innovation and access “to agree on strategies and an accountability framework that will accelerate efforts towards promoting innovation and ensuring access…. ”

Civil society should be financially supported to participate and submit their reports on innovation and access to health technologies at this Special Session, the report says.

R&D, Production, Pricing, Transparency

The report says, “Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to:

(1) the costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and

(2) any public funding received in the development of the health technology, including tax credits, subsidies and grants,” says the report.

The WHO is called to establish and maintain an “accessible international database of prices of patented and generic medicines and biosimilars in the private and public sectors of all countries where they are registered.”

The report also asks that government establish and maintain publicly accessible databases with patent information status and data on medicines and vaccines. This information, the panel said, should be periodically updated and consolidated by WIPO in collaboration with stakeholders to develop an international easily searchable database including standard international common names for biological products, and international non-proprietary names for products, either as known at the time of application or after the granting of a patent, and the dates of grant and expiry.

The report underlines policy incoherence and says that “policies that have a bearing on access to health technologies that are associated with trade, intellectual property, health and human rights were developed with different objectives and at different periods in history. Each is governed by its own legal and regulatory regime and each imposes obligations that may not align with the others.”

The intergovernmental South Centre secretariat issued this statement:

“The report of the UN SG HLP on Access to Medicines reflects the outstanding ability of the chair Ruth Dreifuss and co-chair Gontebaneye to build a consensus among a panel with a wide range and even conflicting opinions.
The report signals that significant progress can be made on many of the pending issues in the international debate on access to medicines. The South Centre encourages the UN General Assembly to welcome the report of the UN SG HLP on Access to Medicines and to agree to a mechanism for overseeing the implementation of the recommendations.”

Civil Society: “Landmark Report”

Médecins Sans Frontières (MSF – Doctors Without Borders) said in a release that the report outlines the global failure of the medical research system to develop medicines, vaccines, and diagnostics that address unmet medical needs affecting communities across the globe.

“MSF welcomes the panel’s recommendations on the need for new incentives for research and development, for greater transparency, as well as for strategies to deal with intellectual property barriers, all with the aim of improving medical innovation and access to health technologies,” the release said.

“MSF urges governments and industry to rapidly implement the recommendations of the High-Level Panel’s report, including demanding more transparency from pharmaceutical corporations on research and development costs and prices, breaking the link between the way research and development is funded and how much companies charge for lifesaving medical tools, and minimising existing barriers, in particular intellectual property-backed monopolies, that undermine access to affordable medicines and vaccines.”

Bernard Pécoul, executive director of the Drugs for Neglected Diseases initiative (DNDi), said in a release: “Governments mustn’t allow the report to become yet another exercise that describes the current failures of the medical innovation system without contributing concrete steps to address those failures. Responsibility now clearly falls on them at the highest political levels to act by putting in place innovative and practical solutions.”

“We welcome the call for the UN Secretary-General to set up a process where governments will negotiate an R&D Convention, based on the principle of delinkage, so that medical innovation can be steered towards public health priorities and deliver affordably priced products. Sustainable solutions are needed, ” he added.

James Love, the Director of Knowledge Ecology International, said in a statement:

“The UN panel has recommended governments embrace new ways to pay for innovation and to increase access to health technologies. Under the current system, we rely too much on high drug prices to incentivize innovation, and this reduces access. The most important recommendations from the UN experts is to delink the cost of R&D from the prices of drugs. You cannot rely upon high drug prices to finance R&D without harming patients and creating unequal access. Policy coherence means making innovation and access happen at the same time. Delinkage is key to policy coherence.

“The panel makes a number of other helpful recommendations, such as those endorsing more transparency of the economics of drug development and marketing, the elimination of pressure on countries that use compulsory licenses to curb high drug prices, and encouraging companies to license patents to generic competitors in developing countries. All of these measures are important and useful.”

Winnie Byanyima, executive director of Oxfam, and a member of the High-Level Panel, said in a statement:

“This report gets to the heart of the problem with access to medicines – that the intellectual property rules promoted by the pharmaceutical industry are at odds with the human right to health. If implemented the report’s recommendations will go a long way towards ensuring all people have access to affordable quality medicines.

“Access to medicines is not just a poor country problem. The high price of drugs is crippling healthcare systems across the world. Millions of people are suffering and dying because the medicines they need are too expensive. The UN should work with governments to ensure the report’s recommendations are acted upon straight away.”

Oxfam listed a variety of instances of high prices on medical products. It concludes with a call for the UN to “take further steps to explore more bold recommendations such as immediate ban on intellectual property rules in trade agreements.”

Canadian HIV/AIDS Legal Network Executive Director Richard Elliott said in a release that the statement made in the report that free trade agreements endanger countries’ efforts to ensure access to medicines, means Canada and other countries should not ratify the Trans-Pacific Partnership agreement as it stands.

“[T]he panel notes that countries concluding such agreements are in dereliction of their human rights obligations by doing so before undertaking a transparent, public assessment of its impact on access to medicines and public health,” he said.

Health GAP was a little more critical, stating: “Unfortunately, while the Panel’s report also recommends specific progress on transparency and more open access to the fruits of university and publicly supported research, the Panel was unable to reach consensus on bold recommendations concerning the limits of the WTO’s Agreement on TRIPS framework to protect access to medicines. Instead, the Panel opined that the right of access to medicines and other health technologies could be resolved within the existing framework of TRIPS flexibilities – a premise that we strongly reject.”

Health Action International also commended the report for “recommending alternative innovation models that embrace the concept” of delinkage, and for calling for a binding R&D Convention that includes a Code of Principles for Biomedical R&D.

This international framework, said HAI, also proposed in 2012 by the World Health Organization’s Consultative Expert Working Group on Research and Development (CEWG), “would improve the coordination of global R&D and secure sustainable financing mechanisms.”

HAI also supports the panel’s call for governments to develop strong, enforceable policies that enable data sharing and data access as a condition of public grants for R&D, support open models of innovation, and a public health approach to managing resulting intellectual property.”

Negative Response from Industry

Industry responses are coming in, and they are showing disappointment.

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) in a release said the panel’s recommendations “ignore the most common issues that hamper access to medicines.”

“Key issues to address are financing for health, improvements in health infrastructures, and enhancement of healthcare worker capacity and patients’ literacy. The majority of the HLP recommendations fail to recognize these complexities as well as the many existing and innovative efforts already taking place to advance access to care in the last two decades.”

“Nearly every important medicine of the last century-and-a-half — including antibiotics, vaccines, HIV and HCV treatments, cancer and cardiovascular medicines — owes its existence to the R&D activities of the biopharmaceutical industry,” the release said.

The US Chamber of Commerce industry group issued a release with the sharp title, “U.S. Chamber Condemns UN Report Attacking Patents.” The Chamber’s Global Intellectual Property Center (GIPC) Executive Vice President Mark Elliot in the statement charged that the panel had pre-set conclusions and missed the real causes of high prices and limiting availability. He also cited the US government’s concerns and criticism about the panel.

“The UN High-Level Panel on Access to Medicines has issued a report that was never intended to address the true barriers of access to medicines; it was designed to drive a narrow and extreme agenda,” he said. “The Panel’s predetermined conclusions ignored decades of data and the input of key countries in asserting that intellectual property is the problem with access to medicines.”

“In doing so, the Panel ignored the real culprits that stand between patients and care: excessive tariffs and taxes on imported medicines, and weak healthcare infrastructures that hinder the effective distribution of medicines,” Elliott continued. “And the UN’s own data shows that intellectual property does not restrict access to medicines: 95 percent of essential medicines are no longer under patent.”

“The irony is that by singling-out patents, this report has attacked the innovative systems that have actually produced thousands of cures and saved millions of lives. Decades of research have shown that the private sector is responsible for as much as 97 percent of drug development. If adopted, these recommendations could prohibit the creation of future breakthrough treatments,” he said.

“The Panel called on governments to drastically restrict patentability of medical innovations; make liberal use of compulsory licenses to override patents; minimize the private sector role in the research and development of new cures; and, put the United Nations itself above national governments in oversight of intellectual property rights,” the Chamber representative concluded.

In the Commentaries section of the report (p.65), panellist Andrew Witty, the GlaxoSmithKline CEO, gave some encouraging words, but lashed out at parts of the report.

“Nobody would dispute the need for improvement in both innovation of healthcare technology and access to it,” Witty said. But he hailed the advances in medical technologies, including through partnerships and collaborations, and the enormous progress and contributions made in the past decade or two, which he said are often taken for granted. These have been largely brought about by intellectual property, he said.

While praising the panel’s introduction of and encouragement for some “new areas of focus,” Witty sought to steer attention away from the TRIPS agreement. New areas he highlighted were “the responsibility of Governments to transparently reconcile their policy choices as they affect access, the role of private sector employers in helping to protect their employees’ health, and the scope to explore delinkage approaches in specific areas of market failure such as AMR [antimicrobial resistance].”

But other recommendations, he said, “suffer from a lack of rigorous testing, sometimes based on assertion rather than data/evidence, and some are vague, lacking clarity on how they will be progressed – for example, what will the development of a Code of Principles for Biomedical R&D address, and what patent rights would publicly-funded R&D be entitled to?” But he doesn’t dismiss the questions, saying, “These subjects will need much more exploration.”

Then he asserted that the report makes two “false or at least highly dubious implicit assumptions,” including that the clinical or financial value of an innovation is clear at the time of discovery and patenting. “It almost never is,” he said.

The second is that national governments will commit or be able to raise the large sums of funding needed to incentivise future innovation.

Witty also urged caution on use of compulsory licences for medical products, and noted that the panel could not agree on this issue. And he contended with the suggestion that information about the costs of developing an innovation should be shared with regulatory authorities, and opposed consideration of patentability criteria related to health.

In the end, Witty does not dismiss most considerations of the panel out of hand, but invites a more thorough analysis in order to determine what should be done.

The Biotechnology Innovation Organization (BIO) found that the report “ignores the real issues that impact or delay delivery of innovative treatments and cures throughout the developing world, while focusing on policy recommendations in the one area – intellectual property – that would actually undermine ongoing research and development by hundreds of companies, universities and researchers.”

BIO said the report fails to acknowledge a large body of evidence and research demonstrating that intellectual property is not at the heart of the access to medicines issue, it said in a statement. “They remarked that the innovative biopharmaceutical industry is committed to removing barriers to healthcare access throughout the world,” and added that the panel should have provided the opportunity for “an informed, balanced and inclusive dialogue.”

Dreifuss Responds to Industry Concerns

Panel Co-Chair and former Swiss President Ruth Dreifuss, responded to industry concerns in an email to Intellectual Property Watch.

“The HLP is absolutely aware that the right of property is rooted in international instruments,” said Dreifuss. “It is also aware that the biomedical corporation have to finance their R+D investment. First, in the case a partial “expropriation” for public need is operated, it has to follow transparent procedure and to be financially compensated. Second, transparency of R+D expenditure creates a better climate for a fair price determination in the countries with price regulation.”

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